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Record W4380083530 · doi:10.1002/hon.3164_386

Matching‐adjusted indirect comparison of axicabtagene ciloleucel versus mosunetuzumab in relapsed/refractory follicular lymphoma patients after 2 prior systemic treatments

2023· article· en· W4380083530 on OpenAlexaff
M. D. Ray, Steve Kanters, Sara Beygi, Timothy Best, Jacob Wulff, Eve H. Limbrick‐Oldfield, Anik R. Patel, Olalekan O. Oluwole

Bibliographic record

VenueHematological Oncology · 2023
Typearticle
Languageen
FieldMedicine
TopicCAR-T cell therapy research
Canadian institutionsRaincoast Conservation Foundation
Fundersnot available
KeywordsMedicineFollicular lymphomaInternal medicineOncologyHazard ratioProportional hazards modelFludarabineClinical trialAlemtuzumabProgression-free survivalRefractory (planetary science)LymphomaOverall survivalConfidence intervalChemotherapyTransplantationCyclophosphamide

Abstract

fetched live from OpenAlex

Introduction: Follicular lymphoma (FL) is an indolent form of non-Hodgkin’s lymphoma; however, relapsed/refractory (R/R) FL patients tend to have poor outcomes. Axicabtagene ciloleucel (axi-cel) was the first chimeric antigen receptor (CAR) T-cell therapy approved for R/R FL patients. More recently, mosunetuzumab was the first bispecific monoclonal antibody approved in R/R FL. We sought to conduct a matching-adjusted indirect comparison (MAIC) to estimate the comparative efficacy and safety of axi-cel and mosunetuzumab for the treatment of 3rd line or higher (3L+) FL. Methods: The evidence base consisted of individual patient data (IPD) from the single-arm axi-cel trial, ZUMA-5, and publications identified through a systematic review pertaining to the mosunetuzumab trial (NCT02500407). For each outcome, prognostic factors—including progression within 24 months of frontline initiation (POD24), refractory status, double refractory, prior stem cell transplant—were a priori identified through quantitative analysis and clinical experts. Outcomes were progression-free survival (PFS), duration of response (DoR), objective response rate (ORR), complete response rate (CRR), and safety. Analyses used independent central review for both trials, where possible. Overall survival (OS) was not analyzed as mosunetuzumab data were immature and not reported in the latest publication. As IPD for axi-cel and aggregate data for mosunetuzumab were available, unanchored MAICs were conducted to align ZUMA-5 to the patient characteristics of the mosunetuzumab trial. Hazard ratios (HRs) from Cox regression were used to compare time-to-event outcomes using pseudo-IPD extracted from published Kaplan-Meier plots for mosunetuzumab and the remaining outcomes were compared using odds ratios (ORs). Index date for ZUMA-5 was date of leukapheresis and included all enrolled patients. Results: Patient characteristics were generally well-aligned between trials leading to large effective-sample sizes after matching, ranging from 99.2 to 109.9, for ZUMA-5 (n = 127). In comparisons to mosunetuzumab (n = 90), axi-cel was associated with improved PFS (HR: 0.38; 95% confidence interval [CI]: 0.23–0.61) and DoR (HR: 0.45; 95% CI: 0.26–0.77). Results were consistent for response outcomes (Figure 1). Sensitivity analyses led to similar results. Although axi-cel was associated with a higher rate of all-grade cytokine release syndrome (CRS) and neurological events (NE), differences in Grade ≥3 (G3+) CRS and treatment-related adverse events (TRAEs) were not statistically significant. Differences in G3+ NE were not evaluable. The research was funded by: Kite, A Gilead Company Keywords: Cellular therapies, Indolent non-Hodgkin lymphoma Conflicts of interests pertinent to the abstract. M. D. Ray Employment or leadership position: Gilead/Kite Stock ownership: Gilead/Kite S. Kanters Employment or leadership position: RainCity Analytics Research funding: RainCity Analytics S. Beygi Employment or leadership position: Gilead/Kite Research funding: Gilead/Kite T. Best Employment or leadership position: Gilead/Kite Stock ownership: Gilead/Kite J. Wulff Employment or leadership position: Gilead/Kite Stock ownership: Gilead/Kite E. H. Limbrick-Oldfield Employment or leadership position: RainCity Analytics A. R. Patel Employment or leadership position: Gilead/Kite Stock ownership: Gilead/Kite O. O. Oluwole Consultant or advisory role: Pfizer, Gilead/Kite, AbbVie, Janssen, TGR Therapeutics, ADC, Novartis, Epizyme, Curio Science, Nektar, Syncopation Honoraria: Pfizer, Gilead

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.000
metaresearch head score (Gemma)0.000
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMeta-epidemiology (narrow)
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Observational · Consensus signal: Observational
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.097
Threshold uncertainty score1.000

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0000.000
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0020.000
Bibliometrics0.0000.001
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0010.000
Insufficient payload (model declined to judge)0.0010.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.066
GPT teacher head0.363
Teacher spread0.298 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

Study designObservational
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations4
Published2023
Admission routes1
Has abstractyes

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